The NeVasc Aspiration System consists of 1) NeVasc Aspiration Catheter, 2) Peel away Introducer Sheath and 3) an Aspiration Tubing Set NeVasc Aspiration Catheter:The NeVasc Aspiration Catheter (also referred to as NeVasc Catheter) is a single lumen, reinforced, flexible, variable stiffness composite catheter. The catheter distal shaft has an external hydrophilic coating aimed to reduce friction during use. The distal end of the catheter shaft is radiopaque for angiographic visualization, and the proximal end contains a luer hub that allows attachment of accessories for flushing and aspiration. Complete dimensions of the catheter are included on the device label.The Peel-Away Introducer is an accessory provided with the catheter to aid in the delivery of the catheter. The NeVasc Catheter and a Peel-Away Introducer are packaged together, they are provided sterile, non-pyrogenic, and are intended for single use only. Aspiration Tubing Set:As part of the NeVasc Aspiration System, the Vesalio Aspiration Tubing Set is provided with a flow switch and is intended to connect the NeVasc Catheter to a compatible aspiration pump. The Aspiration Tubing Set is intended for single use and is provided in a separate package.
A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.